Status:
COMPLETED
A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients
Lead Sponsor:
Augusta University
Collaborating Sponsors:
American Heart Association
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorr...
Detailed Description
MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subseque...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Intracerebral hemorrhage documented by CT scan
- The first dose of the drug can be administered within 12 hours of time last known to be at baseline
Exclusion
- Allergy to tetracycline antibiotics
- Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
- Hepatic and/or renal insufficiency (LFT's \>3x upper limit of normal; Creatinine \>2mg/dL)
- History of intolerance to minocycline
- National Institutes of Health Stroke Scale score of 4 or less
- Glasgow Coma Scale score of 5 or less
- Surgical evacuation of hematoma planned within 24 hours
- Secondary intracerebral hemorrhage resulting from trauma, arteriovenous malformation, aneurysm, tumor or other causes
- Thrombocytopenia (platelet count \<75,000/mm3) or coagulopathy (INR \>1.4)
- Previously not independent (prestroke modified Rankin scale score \>2)
- Suspected of not being able to comply with the study protocol
- Unlikely to be available for 90 day follow-up
- Pre-existing Do Not Resuscitate (DNR) order or indication that a new DNR order will be implemented within the first 48 hours of hospitalization
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01805895
Start Date
February 1 2013
End Date
December 1 2016
Last Update
April 26 2018
Active Locations (1)
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1
Georgia Health Sciences University
Augusta, Georgia, United States, 30912